Co-Diagnostics receives CE mark for Zika screening test

Co-Diagnostics received a CE mark for the most recent version of its Zika virus molecular diagnostic test.

Dwight Egan, CEO of Co-Diagnostics, said the marking is a step toward meeting demand in one of the Utah-based company’s key target markets.

“Given the ability of Zika infections to be passed along through mosquito vectors as well as sexual transmission, the key component to preventing the occurrence of these tragic developmental disorders is an early, accurate, and affordable diagnosis for both men and women,” Egan said in a statement.

According to the World Health Organization, there have been few to no confirmed cases of mosquito-based Zika virus transmission in Europe—although the same species of mosquito, Aedes aegypti, is present in certain geographic areas. The WHO recommends that certain European countries remain on alert for the disease.

The Logix Smart Zika Test uses polymerase chain reaction technology to detect the presence or absence of the virus. The company’s platform is designed to reduce the occurrence of “primer-dimers,” a potential byproduct in PCR testing that can produce a false positive result when primer molecules attach to each other, Egan said.

Co-Diagnostics is also developing a test on the platform to distinguish between Zika, dengue fever and chikungunya, three mosquito-borne diseases typically seen together in certain regions.

The Logix Smart Zika test will be manufactured at the company’s location in Utah, although Co-Diagnostics is currently not pursuing FDA approval due to the low rate of domestic Zika incidents.